Coagulation; Intravascular, Fibrinolysis; Hemorrhage, Rotational Thromboelastometry, Total Hip Arthroplasty, Tranexamic Acid
Conditions
Keywords
tranexamic acid, Rotational thromboelastometry, Fibrinolysis, viscoelastic essay
Brief summary
Total hip arthroplasty (THA) is associated with blood loss ranging from 300 to 2000 mL. Tranexamic acid (TXA) is frequently administered prophylactically during this procedure to reduce blood loss by inhibiting fibrinolysis or by stopping naturally occurring clot resolution. TXA is employed currently based on a surgeon's preference. The objective of this study is to quantitate the degree of fibrinolysis using rotational thromboelastometry (ROTEM) and investigate the role of TXA prophylaxis on blood loss in patients undergoing THA in a double-blind fashion. Our hypothesis is that fibrinolysis is minimal at most and TXA prophylaxis is not necessary during THA. All patients, whether they receive TXA or normal saline, will not be at risk, as at this time no data exists to determine which approach is safer or more effective. This is the first study to compare TXA vs. placebo in a double-blinded, randomized controlled trial.
Detailed description
Total hip arthroplasty (THA) is associated with moderate blood loss ranging from 300 to 2000 mL. Tranexamic acid (TXA) is frequently administered prophylactically during this procedure to reduce blood loss by inhibiting fibrinolysis. Most clinical studies reported potential benefit of the treatment demonstrated by less estimated blood loss (EBL), reduced hemoglobin/hematocrit (HH) change, and reduced transfused packed red blood cells (PRBC). However, bleeding complication may be affected more significantly by the degree of surgical trauma and comorbidity of patients than coagulation abnormality. Further, the frequency and severity of fibrinolysis during these procedures have not been well studied. Additionally, TXA administration may increase the tendency of postoperative venous thrombosis by inhibiting fibrinolysis in already prothrombotic patients. The objective of this study is to quantitate the degree of fibrinolysis using rotational thromboelastometry (ROTEM) and investigate the role of TXA prophylaxis on clinical outcome in patients undergoing THA in a double-blind fashion. Our hypothesis is that fibrinolysis is minimal at most and TXA prophylaxis is not necessary during primary THA.
Interventions
DRUGTranexamic Acid
tranexamic acid will be administered intravenously after induction of anesthesia (a bolus of 10 mg/kg or maximal dose of 1g).
DRUGPlacebo
Patients in the placebo group will receive normal saline (a bolus of sodium chloride 0.9%, 0.1 mL/kg or maximal dose of 10 mL).
Sponsors
Thomas Jefferson University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Intervention model description
double-blinded randomized controlled trial
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* The study population will include total of 200 adults (age range of 18 - 85 years) who are in the American Society of Anesthesiologists (ASA) Physical Status (PS) 1-3. Inclusion criteria are patients undergoing unilateral, primary, total hip arthroplasty.
Exclusion criteria
*
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fibrinolysis | after induction of anesthesia (baseline), | Fibrinolysis based on ROTEM parameter, defined as ML (maxium lysis) \>15% |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| blood transfusion | Intraoperative and up to 72-hour after surgery | Amount of Packed Red Blood Cells (PRBC) transfused |
| pre- and postoperative hemoglobin level | up to 72-hour after surgery | Pre and postoperative hemoglobin level in grams per deciliter |
| Blood loss | during surgery (intraoperative) | amount of blood loss in milliliter during surgery |
| Hematoma | up to72-hour after surgery | Incidence of hematoma |
| Thrombotic events (PE, DVT). | up to 72-hour after surgery | Incidence of thrombotic events (pulmonary embolism, deep vein thrombosis) |
| Wound infection | up to 72-hour after surgery | Incidence of wound infection |
Countries
United States
Outcome results
None listed